ProfTalks
Presentations on pharmaceutical guidelines (ICH guidelines, USFDA guidelines, EU Guidelines), Regulations, interview preparation and professional development.
Glenmark Warning Letter July 2025 | USFDA Warning Letters
Stability Study ICH Guidelines Q1A, Q1B & Q1C | Stability approach | Stress testing | Photostability
Zydus Vadodara Warning Letter Sep 2024 | Learning through USFDA Warning Letters
Biocon Bangalore 483's July 2024 USFDA Inspection | Learning through 483 Observations
Zydus Vadodara 483 Observation Apr 2024
Biocon Malaysia 483 Observations July 2023 | Learning from USFDA 483s
Nitrosamine Impurities-Aug 2023 NDSRIs Limit USFDA Guidance | Control of Nitrosamine Guidance Feb-21
Medgel Pharma Indore Warning Letter 20 July 2023 | Learning from USFDA Warning Letters
Baxter Pharma Warning Letter 25 July 2023 Ahmedabad | Learning from USFDA Warning Letters
Intas Pharma Warning Letter 28 July 2023 | Learning from USFDA Warning Letters | 2023 Warning Letter
Ipca Laboratories Indore USFDA 483 June 2023 | learning from 483's
USFDA Inspections: Overview | Difference between USFDA Inspection & Other Authority Inspections
Centaur Pharma Warning Letter June 2023 USFDA | Learning from Warning Letter
Intas Ahmedabad 483 Observation May 2023 | Learning from 483s
IPCA Laboratories Ratlam 483 Observation June 2023 | Learning from Observations | API Facility
Revised ICH Q9 (R1) Quality Risk Management Guideline | Jan 2023
Quality Metrics Data Submission USFDA Guidance| USFDA Guidelines |
ICH Q12 Управление жизненным циклом продукта
ICH Q3C Guidance for Residual Solvents | Class of Residual Solvents | PDE Values of Residual Solvent
21 CFR Part 11 | Electronic Records & Electronic Signatures | GxP Computer System requirements
Revised EU Annex 1- Manufacture of Sterile Products (25 Aug 2022) | Comprehensive Training Module
ICH Q3D Guidance for Elemental Impurities | Example for calculating | Permitted Daily Dose (PDE)
Revised Out of Specification (OOS) Guidance | USFDA Guidance | OOS Guidance May 2022
ICH Q9 Guidance for Quality Risk Management | With simplified example
USFDA Guidance for Data Integrity | USFDA Guidelines for Pharmaceutical | Easy Explanation
Quiz on USFDA Guidance on Pharmaceutical Quality System & ICH Q10 | USFDA Guidance | ICH Guidance |
Руководство ICH Q10 по фармацевтической системе качества | Руководство для фармацевтической промы...
USFDA Guidance for Pharmaceutical Quality System | USFDA Guidelines for Pharmaceuticals |
How to answer the interview question on 'What are your strengths?' | Interview question
Don'ts of Interview | Things not to talk about in the interview